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Evaluation of Long-term Effect of Resonator Therapy on Parkinson's Disease (PD)

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Resonator Device
Sponsored by
pico-tesla Magnetic Therapies, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Parkinson's Disease

Eligibility Criteria

30 Years - 82 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Prior participation in pico-tesla pilot studies: NCT00779155 & NCT00863226
  • Willing and able to abstain from partaking in non-essential new treatments for Parkinson's disease symptoms during the course of participation of the study.
  • Will and able to abstain from all non-essential new medications that could affect PD and/or any of its associated symptoms for the duration of the study.
  • Willing to notify the investigator right away of any changes in medication use or therapies that is prescribed and deemed necessary by the subjects physicians.
  • Adequate contraceptive measures for female subjects
  • Capable of giving full written informed consent

Exclusion Criteria:

  • Not a participant in IRC#'s 07102 or 07021
  • No active brain tumors, strokes, hydrocephalus
  • Chronic pain not associated with PD
  • Any other condition which might prevent subject from comfortably sitting for 1.5 hours
  • Consumption of medications that can produce Parkinsonism type symptoms
  • Major psychiatric disturbance
  • Epilepsy
  • HIv and other autoimmune disorders
  • Cancer within last 2 years
  • History of ECt
  • Diabetic neuropathy
  • Uncontrolled HTN
  • Advanced Pulmonary disease
  • Known heart conditions such as repetitive history of cardiac arrythmias
  • Previous surgeries for PD
  • Prosthetics comprised of ferrous materials
  • Stents, only where there is also cardiac arrythmias, CHF, advanced valvular stenosis, unstable vital signs, extensive ischemic damage to heart muscle as a result of one or more heart attacks.
  • Pacemakers
  • Uncontrolled, unstable, or untreated medical illnesses which might potentially significantly affect the patient's health in the opinion of the investigator
  • Consumption of more than 21 alcoholic drinks per week
  • Pregnant, breast feeding or planning pregnancy
  • Developmental disability or cognitive impairment
  • Inability to maintain regular medication regime
  • Inability to abstain from partaking in new non-essential PD tx., or medications
  • Not willing to report physician mandated changes in medication and/or treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Arm Label

    Active Resonator magnetic field therapy

    Arm Description

    Administration of active magnetic fields with the Resonator Device

    Outcomes

    Primary Outcome Measures

    Change in Parkinson's Disease Questionnaire-39 Single Index Score (PDQ-39SI)From Baseline to Study Endpoint of 11 Months
    The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item quality of life questionnaire for patients with Parkinson's Disease (PD) that evaluates the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, and communication. The PDQ-39 Single Index (SI) score is the weighted addition of scores on all 8 dimension and ranges from 0 (no disease impact) to 100 (severe disease impact).

    Secondary Outcome Measures

    Full Information

    First Posted
    October 22, 2008
    Last Updated
    June 9, 2011
    Sponsor
    pico-tesla Magnetic Therapies, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00862537
    Brief Title
    Evaluation of Long-term Effect of Resonator Therapy on Parkinson's Disease (PD)
    Official Title
    An Open-label Extension Study for Subjects Previously Treated Either in Pilot I or Pilot II Studies of the Application of Magnetic Fields Using the Resonator for the Treatment of Parkinson's Disease.
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    June 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2008 (undefined)
    Primary Completion Date
    April 2011 (Actual)
    Study Completion Date
    April 2011 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    pico-tesla Magnetic Therapies, LLC

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    An extension study for subjects with prior participation in previous resonator studies using low level magnetic fields to treat some of the symptoms of idiopathic Parkinson's Disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease

    7. Study Design

    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Active Resonator magnetic field therapy
    Arm Description
    Administration of active magnetic fields with the Resonator Device
    Intervention Type
    Device
    Intervention Name(s)
    Resonator Device
    Intervention Description
    active pico-tesla magnetic fields treatment for Parkinson's disease individuals
    Primary Outcome Measure Information:
    Title
    Change in Parkinson's Disease Questionnaire-39 Single Index Score (PDQ-39SI)From Baseline to Study Endpoint of 11 Months
    Description
    The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item quality of life questionnaire for patients with Parkinson's Disease (PD) that evaluates the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, and communication. The PDQ-39 Single Index (SI) score is the weighted addition of scores on all 8 dimension and ranges from 0 (no disease impact) to 100 (severe disease impact).
    Time Frame
    baseline and 11 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    82 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Prior participation in pico-tesla pilot studies: NCT00779155 & NCT00863226 Willing and able to abstain from partaking in non-essential new treatments for Parkinson's disease symptoms during the course of participation of the study. Will and able to abstain from all non-essential new medications that could affect PD and/or any of its associated symptoms for the duration of the study. Willing to notify the investigator right away of any changes in medication use or therapies that is prescribed and deemed necessary by the subjects physicians. Adequate contraceptive measures for female subjects Capable of giving full written informed consent Exclusion Criteria: Not a participant in IRC#'s 07102 or 07021 No active brain tumors, strokes, hydrocephalus Chronic pain not associated with PD Any other condition which might prevent subject from comfortably sitting for 1.5 hours Consumption of medications that can produce Parkinsonism type symptoms Major psychiatric disturbance Epilepsy HIv and other autoimmune disorders Cancer within last 2 years History of ECt Diabetic neuropathy Uncontrolled HTN Advanced Pulmonary disease Known heart conditions such as repetitive history of cardiac arrythmias Previous surgeries for PD Prosthetics comprised of ferrous materials Stents, only where there is also cardiac arrythmias, CHF, advanced valvular stenosis, unstable vital signs, extensive ischemic damage to heart muscle as a result of one or more heart attacks. Pacemakers Uncontrolled, unstable, or untreated medical illnesses which might potentially significantly affect the patient's health in the opinion of the investigator Consumption of more than 21 alcoholic drinks per week Pregnant, breast feeding or planning pregnancy Developmental disability or cognitive impairment Inability to maintain regular medication regime Inability to abstain from partaking in new non-essential PD tx., or medications Not willing to report physician mandated changes in medication and/or treatment
    Study Population Description
    Previous participants enrolled in one of two prior pico-tesla Magnetic Therapies Resonator device studies using magnetic fields for treating Parkinson's Disease (PD) symptoms.
    Sampling Method
    Non-Probability Sample
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jerry I Jacobson, PhD., DMD.
    Organizational Affiliation
    pico-tesla Magnetic Therapies, LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Long-term Effect of Resonator Therapy on Parkinson's Disease (PD)

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